Reported Nov 18, 2015 · Terminated

MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
Lot codes and dates
  • model# 1157200
Amount recalled
15

Where it was sold

Why it was recalled

Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 5, 2016 · Data as of Sep 19, 4:44 PM UTC

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